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FDA Can't Cite Evidence of Canadian Drugs' Harm

Posted - Nov. 28, 2003 at 11:20 a.m.



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Although they've been warning Americans about the dangers of prescription drugs from Canada for nearly a year, U.S. Food and Drug Administration officials can't name a single American who's been injured or killed by drugs bought from licensed Canadian pharmacies.

"We don't have that [information]," said Tom McGinnis, the FDA's director of pharmacy affairs. "I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these medications."

Neither does Canada.

Health Canada, which regulates Canada's prescription industry, "does not have any information that would indicate that any Americans have become ill or have died as a result of taking prescription medications purchased from Canada," said Jirina Vlk, a spokeswoman for Health Canada.

That doesn't mean there are no such cases. But the absence of documented harm strongly suggests that medications obtained from licensed Canadian pharmacies are safe, and raises questions about whether the FDA may be overstating the risk of buying less expensive Canadian drugs.

FDA Commissioner Mark McClellan, in a speech last week in Canada before a group of drug information experts, said the agency had found "thousands of examples of unapproved and potentially unsafe medicines" coming into the United States from "many countries, including from Canada."

In a subsequent news conference in Ottawa, McClellan was more specific, according to news reports, saying there were "lots of examples of unsafe drugs coming into the United States from Canada."

A recent report by the Congressional Research Service -- the Library of Congress expert that Congress turns to for objective information -- found that medications made and distributed in Canada meet or surpass quality control guidelines set by the FDA.

FDA Associate Commissioner William Hubbard says the FDA thinks many people don't report adverse incidents that result from using Canadian drugs. That's because they fear being prosecuted for violating federal laws against foreign drug imports, said Carmen Catizone, the executive director of the National Association of Boards of Pharmacy.

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Copyright ©2003 Fort Worth Star Telegram. All Rights Reserved.

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